COMMENTARY

Psoriasis Biologic Therapy During the COVID-19 Era

Candrice R. Heath, MD; Mark G. Lebwohl, MD

Disclosures

April 01, 2021

This transcript has been edited for clarity.

Candrice R. Heath, MD: I am Dr Candrice Heath, guest host for the Dermatology Weekly podcast, and I would like to thank Dr Mark Lebwohl for joining me on the podcast today for another COVID-related conversation. Today we'll be talking about biologics for psoriasis during the COVID pandemic.

He is currently the dean of clinical therapeutics at the Icahn School of Medicine at Mount Sinai and the chairman emeritus of the Mount Sinai Department of Dermatology.

Mark G. Lebwohl, MD: Delighted to be here. Thank you.

Heath: Your name is synonymous with everything psoriasis to many dermatologists and healthcare professionals. We definitely want to hear from you about some of the official recommendations for caring for patients with psoriasis who are on biologics during this COVID-19 pandemic. What would you like to share with us about that?

Lebwohl: Several patient and physician organizations have weighed in on this. We have a tremendous amount of data, considering that this is a virus that has only been with us a little over a year.

I think the organization that has been the most active has been the National Psoriasis Foundation (NPF). They have a superb NPF COVID-19 task force — that I'm a part of — chaired by Joel Gelfand. NPF has looked at literally every article that has come out on the subject.

The American Academy of Dermatology, Skin Inflammation and Psoriasis International Network (SPIN), and the International Eczema Council also have a very active task force.

We have an enormous registry here of 5000 patients. We already have over 3000 in, and we're basically looking at outcomes in patients with atopic dermatitis and psoriasis who are either on biologics or are controlled candidates for biologics that we were comparing.

Heath: With the data that you have collected, what do you think are some of the biggest takeaways that dermatologists should know? What are the warnings about taking care of patients who are living in this time of a pandemic but who also have to take biologics to control their psoriatic disease?

Lebwohl: At the start, I think there was tremendous concern. In fact, I think I was getting up to 600 emails or phone calls a day from colleagues around the world who asked, "What do I do with my patient on secukinumab, ustekinumab, TNF blockers, or IL-23 blockers?"

It was overwhelming. I think we have learned a lot since then. We speculated early on that based on pivotal trial data, the IL-17 and IL-23 blockers would be safe, but we didn't know if the TNF blockers would be. We also didn't know if ustekinumab would be safe.

Well, it turns out that based on COVID-19 data from around the world, especially Italy and New York, being on biologics didn't adversely affect patients.

I'll give you some numbers from northern Italy, where they had vast numbers. [Outcomes of] people with psoriasis or other inflammatory conditions on biologics can't compare to [those of people taking] nonbiologics like methotrexate, low-dose steroids, or 6-MP. The increase in hospitalization was 2.8-fold on the nonbiologics, so it looked like the biologics were even protective. If you compared the death rate in those on biologics with a comparable controlled population, it was reduced by 58%.

The New York numbers were lower, but the same pattern was seen. It appeared that biologics were protective.

The largest grouping of biologics was TNF inhibitors. We were cautious about the TNF blockers, but it turned out that being on TNF blockers was protective. It did appear that being on any biologics was protective.

I will say that psoriasis patients had a drawback. Being on biologics appears to be protective, but psoriasis in general was not because our patients had some of the risk factors that we identified.

Heath: Comorbidities, right?

Lebwohl: Yes. We are talking about patients with hypertension, patients who are obese, patients who had a lot of comorbidities that we clearly now know make COVID-19 worse.

Dupilumab was very interesting because it treats asthma as well as atopic dermatitis. It is very clear that having pulmonary disease was a major risk factor. Certainly, it's early in our registry here at Mount Sinai, but we have 1200 dupilumab patients. I can tell you that it looks dramatically like being on dupilumab is protective. We are seeing that our initial inclination was that biologic therapies are actually not harmful in this setting.

Heath: How does it feel to be at this stage of your career and have something that has really taken off like this? The pandemic has forced us to be okay with the unknown and be okay that papers that we're publishing right now may not even be accurate 6 months from now. How do you feel about the data coming so fast that there's a risk of saying something that is incorrect?

Lebwohl: I will say that as soon as I started getting the 300-600 emails a day, I asked Ryan Rivera-Oyola to collate all of the pivotal trial data from all of the biologics that we had, and a pattern clearly emerged.

We then submitted it as a letter to the editor of the Journal of the American Academy of Dermatology (JAAD) because I didn't want to be subjected to the rigor of a several-weeks wait to get editorial review; we wanted it to get published right away. The turnaround — I have to compliment the JAAD; they saw the urgency of it. It was published in less than a week.

Heath: Wow.

Lebwohl: JAAD went on to publish a lot of the articles on COVID-19 very quickly. We weren't the first to describe skin manifestations, but we published urticarial rash and morbilliform rash very quickly at the beginning of the pandemic. We were able to show that we now had a new manifestation of a virus.

Mount Sinai was swamped by this awful virus. We had tents across the street in the park. At a time, we actually took over a nearby hotel. We had the ship USNS Comfort sent here that we were sending patients to as well. There were beds in our hallways. Many of our staff and residents got the virus. We had no deaths among our staff, but we had three deaths among parents and grandparents of our staff. It was a devastating time.

Video visits replaced office visits within a couple of weeks. We jumped on every opportunity. Through the Foundation for Research and Education in Dermatology, we hosted virtual meetings every week. We have a full clinical virtual grand rounds. The first one was that COVID-19 one, and it was to solve a problem. There was no sponsor for it. We were getting 600 emails and calls a day and our colleagues needed to know what to tell their patients.

Heath: We definitely have academic dermatologists who listen faithfully to this podcast. We have a large majority of dermatologists in private practice. If a practicing dermatologist is far away from an academic center, what are some things that they can tell their patients who are taking biologics so that they will be comfortable with continuing treatment?

Lebwohl: There are several drawbacks that we actually pointed out in that first letter. If you re-treat a patient with the same biologic they came off of, it won't work as well.

For dupilumab, the recapture rate was 83%, which is excellent, but that means 17% don't recapture; 1 out of 6 patients is going to do poorly. You don't want to stop those drugs if you don't have to.

Infliximab was the worst one. They actually have studied it and shown that if you stop and restart infliximab, a high proportion of patients — and in their study it was 38% — develop antibodies to the drug, so it stops working. Then you have to switch to another one that might not have worked as well as the one you were using before.

There is a lot of downside to stopping and restarting biologic therapy.

Many patients are avoiding going to doctors' offices. I would say the FDA and many of the insurers should be complimented because they followed the Medicare plan, which was, I thought, excellent.

Early on, they said you can get your injections at home, even if they're approved only for in-office use. We were teaching patients by video how to give themselves the treatments.

I think we saw many things come together very efficiently and effectively to treat our patients, but still a lot of our patients decided to stop their treatment. It ended up being the wrong decision for many of them.

Heath: One of the hot topics is the COVID-19 vaccine. We have had some recommendations for years about biologics and vaccines. Are the recommendations different for the COVID-19 vaccine because it's new? What should we tell our patients about that?

Lebwohl: All of the biologics carry a "don't take live-virus vaccines" warning. The COVID-19 vaccines approved in the US are not live viruses; they're nucleotide-based mRNA viruses. They pose no danger in terms of live virus warnings. You can take them.

The NPF COVID-19 task forces came out with a recommendation that strongly encourages patients on biologics to take those vaccinations and to not interrupt their biologic therapy. They've also extended that to apremilast, tofacitinib, methotrexate, and other agents.

Don't take a break from these therapies. Stay on them. They are protecting against psoriasis, they're protecting your joints, they're reducing the cardiovascular comorbidities associated with the diseases. So stay on them and get the vaccination. That is what the guideline says.

Heath: Do you have any final thoughts that you would like to share with our listening audience?

Lebwohl: I want to talk about what to do when patients on biologics get COVID-19.

Some of my colleagues say, "No, don't stop taking the biologics," but the package inserts say do. The guidance from the NPF COVID-19 Task Force suggests that dermatologists take this on a case-by-case basis.

If somebody has a horrific disease and they fall apart as soon as you stop their therapy, that would be a different patient from somebody who's stable for months. The package insert does say to stop those drugs during infections; it says it on all of them. That's what we've been doing here, unless we're very worried about a particular patient and have a reason to keep them on that therapy.

A patient with erythrodermic psoriasis who falls apart when you reduce their treatment, we would probably not stop. We also discourage the use of long-term low-dose steroids for psoriatic arthritis because it puts patients at greater risk.

Heath: That task force paper is hot off the press. I'm happy that we have colleagues who have really dedicated their careers to staying on the cutting edge so that the rest of us can focus on other things in our expert areas and we can lean on each other during times like these

Thank you so much again for joining me. I am Dr Candrice Heath, your guest host for the Dermatology Weekly podcast. Thanks again to Dr Mark Lebwohl for sharing his expertise in biologics, psoriasis, and COVID-19.

This has been another COVID conversation with Dr Candrice Heath, your favorite fun, board-certified dermatologist, your go-to girl for everything healthy hair, skin, and nails.

Thank you so much. I look forward to you listening again.

Lebwohl: Thank you, Candrice.

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